Cleared Traditional

ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT (K944845) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944845 · Wrightmedicaltechnologyinc · Orthopedic device
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Dec 1994
Decision
76d
Days
Class 2
Risk

K944845 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K944845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date December 15, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K944845.
ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT
K941755 · Wrightmedicaltechnologyinc · Jan 1995
DARWIN KNEE SYSTEM
K943462 · Johnson & Johnson Professionals, Inc. · Dec 1994
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS
K944285 · Osteonics Corp. · Dec 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · Exactech, Inc. · Dec 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · Osteonics Corp. · Dec 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · Howmedica Corp. · Nov 1994